Midiana - Ethinyl estradiol / Drospirenone uses, dose and side effects

Midiana is a birth control pill used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones , ethinyl estradiol and drospirenone.
Birth control pills that contain two hormones are called combined birth control pills .

What you need to know before using Midiana

Generally

Before you start using Midiana, read the information on blood clots in section 2. You must read the symptoms of blood clots – see section 2, “Blood clots”).

Before you can start taking Midiana, your doctor will ask you some questions about your and your immediate relatives’ health. Your doctor will also measure your blood pressure, and depending on your situation, may also take some other samples.

This information describes several situations where you should stop using Midiana, or when Midiana may be less reliable. In such situations, you should either not have intercourse or use an additional non-hormonal method of contraception, e.g. a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable as Midiana alters the monthly changes in body temperature and cervical secretions.

Midiana, like other hormonal contraceptives, does not protect against HIV infection ( AIDS ) or other sexually transmitted diseases.

Do not use Midiana

Do not use Midiana if you have any of the conditions listed below. If you have any of these conditions, you need to tell your doctor. The doctor will discuss what other type of contraception may be more appropriate.

if you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis , DVT), in your lungs ( pulmonary embolism ) or any other organ
if you know you have a disease that affects blood coagulation – e.g. protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies
if you need to have an operation or if you stay in bed for a longer period (see section “Blood clots”)
if you have had a heart attack or a stroke (stroke)
if you have (or have had) angina (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)
if you have any of the following conditions that may increase the risk of a blood clot in your arteries:
- severe diabetes with damaged blood vessels
- very high blood pressure
- a very high level of fat in the blood ( cholesterol or triglycerides )
- a condition called hyperhomocysteinemia

if you have (or have had) a type of migraine called “migraine with aura”
if you have (or have had) a liver disease and your liver function is not yet normal
if your kidneys are not working properly ( kidney failure )
if you have (or have had) a tumor in your liver
if you have (or have had) or suspect you may have breast or genital cancer
if you have unexplained vaginal bleeding.
if you are allergic to ethinyl estradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). This can cause itching , rash or swelling.
Midiana contains soy lecithin. Do not take this medicine if you are allergic to peanuts or soy.

Do not use Midiana if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir / ritonavir and dasabuvir (see also section “Other medicines and Midiana”).

Children and young people

Midiana is not intended for use in women whose periods have not yet begun.

Warnings and cautions

Talk to your doctor or pharmacist before taking Midiana. Show larger

When should you contact a doctor?
Seek medical attention immediatelyif you notice possible signs of a blood clot that may mean you have a blood clot in your leg (ie deep vein thrombosis ), a blood clot in your lung (ie pulmonary embolism ), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious side effects, go to “How to recognize a blood clot”.

Tell your doctor if any of the following conditions apply to you.

In some situations, you need to be extra careful when using Midiana or any other combined pill and your doctor may need to examine you regularly. If the condition occurs or worsens when you use Midiana, you should also consult a doctor.

if you have a close relative who has had breast cancer
if you have a disease of the liver or gallbladder
if you have diabetes
if you have depression or mood swings
if you have epilepsy (see “Other medicines and Midiana”)
if you have a disease that first appeared during pregnancy or previous use of sex hormones (eg hearing loss, a blood disorder called porphyria , yellow skin or yellow eyes (jaundice), itching all over the body ( pruritus ), skin rash with blisters during pregnancy ( herpes gestationis), a nerve disease that leads to sudden movements of the body (Sydenhams korea)
if you have had a discoloration of the skin, especially on the face or neck called “pregnancy spots”. If you have it, avoid direct sunlight or ultraviolet light
if you have hereditary angioedema . Products that contain estrogen can cause or worsen the symptoms. You should contact your doctor immediately if you experience symptoms of angioedema , e.g. swelling of the face, tongue and / or pharynx and / or difficulty swallowing or hives along with difficulty breathing.
if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
if you have a systemic lupus erythematosus ( SLE – a disease that affects your natural immune system)
if you have hemolytic uremic syndrome (HUS – a disorder of blood coagulation that leads to kidney failure )
if you have sickle cell anemia (a hereditary disease of the red blood cells )
if you have high blood fats ( hypertriglyceridemia ) or a hereditary condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
if you need to have an operation or stay in bed for a longer period (see section 2 “Blood clots”)
if you have just given birth, you are at increased risk of getting blood clots. Ask your doctor how soon after giving birth you can start using Midiana
if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
if you have varicose veins.

BLOOD CLOTS

Using combined hormonal contraceptives such as Midiana increases the risk of blood clots compared to not using these drugs. In rare cases, a blood clot can block the blood vessels and cause serious problems.

Blood clots can form

in veins (called venous thrombosis , venous thromboembolism or VTE)
in the artery (called arterial thrombosis , arterial thromboembolism or ATE).

It is not always possible to fully recover from blood clots. In rare cases, they can have serious lasting effects and, in very rare cases, be fatal.

It is important to remember that the overall risk of a dangerous blood clot due to Midiana is small.

HOW TO FEEL A BLOOD CLOTH AGAIN

Seek medical attention immediately if you notice any of the following signs or symptoms.

Do you experience any of these signs?	What can you possibly suffer from?
swelling of a leg or along a vein in the leg or foot, especially if you also get: pain or tenderness in the leg that is only felt when you stand or walk increased heat in the affected leg discoloration of the skin on the leg, e.g. pale, red or blue	Deep vein thrombosis
sudden unexplained shortness of breath or rapid breathing sudden cough for no apparent reason that could cause you to cough up blood severe chest pain that may increase with deep breathing severe instability or dizziness fast or irregular heartbeat severe pain in the abdomen If you are not sure, talk to a doctor because some of these symptoms, e.g. cough and shortness of breath, can be mistakenly interpreted as a milder condition such as a respiratory infection (such as a common cold).	Pulmonary embolism
Symptoms that usually occur in one eye: immediate loss of vision or blurred vision without pain that can lead to vision loss	Retinal venous thrombosis(blood clot in the eye)
chest pain, discomfort, pressure, heavinesspressure or feeling of fullness in the chest, arm, or below the sternum feeling full, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm and abdomensweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breakfast or irregular heartbeat	Myocardial infarction
sudden weakness or numbness in the face, arms, or legs, especially on one side of the body sudden confusion, difficulty speaking or understanding sudden vision problems in one or both eyes sudden difficulty walking, dizziness, loss of balance or coordination Sudden, severe or prolonged headache without known cause unconsciousness or fainting with or without seizures Sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of having a new stroke.	Stroke
swelling and slight blue discoloration of an arm or leg severe pain in the abdomen ( acute abdomen)	Blood clots that block other blood vessels

BLOOD CLOTS IN A FRIEND

What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in a vein (venous thrombosis ). However, these side effects are rare. They usually occur during the first year of using a combined hormonal contraceptive.
If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).
If a blood clot moves from the bone and stays in the lung, it can lead to a pulmonary embolism .
In very rare cases, a blood clot can form in a vein in another organ such as the eye ( retinal venous thrombosis ).

When is the risk of developing a blood clot in a vein greatest?

The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk can also be higher if you start again with a combined hormonal contraceptive (same product or another product) after a break of 4 weeks or longer.

After the first year, the risk decreases, but it is always slightly higher than if you did not use a combined hormonal contraceptive.

When you stop using Midiana, the risk of a blood clot returns to normal within a few weeks.

How big is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The total risk of a blood clot in the leg or lungs with Midiana is small.

Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5–7 develop a blood clot in one year.
Of 10,000 women who use a combined hormonal contraceptive that contains drospirenone such as Midiana, about 9-12 develop a blood clot in one year.
The risk of a blood clot varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).

	Risk of developing a blood clot during a year
Women who do not use a combined hormonal contraceptive (birth control pill/patch/ring) and who are not pregnant	About 2 out of 10,000 women
Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate	About 5-7 out of 10,000 women
Women using Midiana	About 9-12 out of 10,000 women

Factors that may increase the risk of a blood clot in a vein

The risk of a blood clot with Midiana is small but some conditions increase the risk. The risk is higher:

if you are overweight (body mass index or BMI over 30 kg / m ² )
if a close relative has had a blood clot in the bones, lungs or other organ at a young age (eg under 50 years). In this case, you may have a hereditary blood clotting disease
if you need to undergo surgery, or stay in bed for an extended period of time due to injury or illness, or if your leg is plastered. The use of Midiana may need to be stopped several weeks before surgery or while you are less mobile. If you have to stop taking Midiana, ask your doctor when you can start taking it again
with increasing age (especially if you are over about 35 years old)
if you gave birth a few weeks ago

The more conditions you have, the greater the risk of developing a blood clot.

Air travel (over 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other factors listed here.

You must tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that you need to stop taking Midiana.

If any of the above conditions change when you use Midiana, e.g. A close relative suffers from a blood clot with an unknown cause, or you gain a lot of weight, talk to your doctor.

BLOOD CLOTS IN AN ART

What can happen if a blood clot forms in an artery?

In the same way as a blood clot in a vein, a clot in an artery can lead to serious problems. It can e.g. cause a heart attack or stroke.

Factors that may increase the risk of a blood clot in an artery

It is important to know that the risk of a heart attack or stroke due to the use of Midiana is very small but may increase:

with increasing age (after about 35 years of age)
if you smoke. When using combined hormonal contraceptives such as Midiana, you should stop smoking. If you can not stop smoking and are over 35 years old, your doctor may advise you to use another type of contraceptive
if you are overweight
if you have high blood pressure
if a close relative has had a heart attack or stroke at a young age (younger than 50 years). In this case, you may also be at greater risk for a heart attack or stroke
if you or a close relative have high blood fats ( cholesterol or triglycerides )
if you get migraines , especially migraines with an aura
if you have heart problems (valve disease, a heart rhythm disorder called atrial fibrillation )
if you have diabetes .

If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot can be even greater.

If any of the above conditions change when you use Midiana, e.g. If you start smoking, a close relative suffers from thrombosis of unknown cause, or you gain a lot of weight, talk to your doctor.

Midiana and cancer

Breast cancer has been observed slightly more often in women using combined oral contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who use combined contraceptive pills because they are examined more often by doctors. The risk of breast tumors gradually decreases after you stop using combined hormonal contraceptives. It is important that you check your breasts regularly and that you consult a doctor if you feel a lump.

In rare cases, benign liver tumors, and in even more rare cases, malignant liver tumors, have been reported in birth control pill users. Contact your doctor if you have unusually severe abdominal pain.

Mental disorders

Some women who use hormonal contraceptives, including Midiana, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.

Bleeding between periods

During the first months of taking Midiana, you may experience unexpected bleeding (bleeding outside the seven tablet-free days).

If this bleeding occurs for more than a few months, or if it starts after a few months, contact a doctor as he/she needs to check if something is wrong.

Do this if you do not experience any bleeding during the seven tablet-free days

If you have taken all the tablets correctly, have not vomited or had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.

If the expected bleeding does not occur twice in a row, you may be pregnant. Contact a doctor immediately.

Do not start with the next tablet card until you are sure you are not pregnant.

Other medicines and Midiana

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Also, tell other doctors or dentists who prescribe other medicines (or your pharmacist) that you are taking Midiana. They can tell you if you need to use additional protection (eg condoms) and if so for how long, or if they use another medicine you need needs to be changed.

Do not use Midiana if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause elevated liver function levels in the blood (increase in the liver enzyme ALT ).

Your doctor will prescribe another type of contraceptive before you start treatment with these drugs.

You can start Midiana again about 2 weeks after stopping this treatment. See section “Do not use Midiana”.

Some medicines can affect the blood levels of Midiana and make it less effective in preventing pregnancy or causing unexpected bleeding. This includes drugs used to treat

epilepsy (eg barbiturate , carbamazepine, phenytoin , primidone, felbamate, oxcarbazepine, topiramate)
tuberculosis (eg rifampicin)
HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, eg ritonavir, nevirapine, efavirenz
high blood pressure in the blood vessels of the lungs ( bosentan )
fungal infections (eg griseofulvin, ketoconazole )
treatment of the symptoms of osteoarthritis (etoricoxib)
the natural remedy St. John’s wort (Hypericum perforatum). If you want to use St. John’s wort while you are taking Midiana, consult your doctor first.

Midiana may affect the effectiveness of other medicines, e.g.

ciclosporin (medicine used to prevent transplant rejection )
the epilepsy drug lamotrigine (this may lead to an increased number of seizures)
tizanidine (medicine used to treat muscle cramps)
theophylline (medicine used to treat asthma ).

Ask your doctor or pharmacist for advice before taking any medicine

Midiana with food and drink

Midiana can be taken with or without food, if necessary with a small amount of water.

Laboratory samples

If you are taking blood samples, tell your doctor or laboratory staff that you are taking birth control pills as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Midiana if you are pregnant. If you become pregnant while taking Midiana, stop taking the medicine immediately and consult a doctor. If you want to get pregnant, you can stop taking Midiana at any time (see also “If you stop taking Midiana”).

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Women should not take Midiana while breastfeeding. If you want to take birth control pills while breastfeeding, contact your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There is no information to suggest that Midiana affects the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Midiana contains lactose and soy lecithin

Midiana contains 48.17 mg of lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Midiana also contains 0.07 mg of soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

How to take Midiana

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Take one tablet of Midiana daily, if necessary with some water. You can take the tablets with or without food, but you should take the tablets every day at about the same time.

The tablet map contains 21 tablets. Next to each tablet is printed which day of the week you should take it. If you e.g. starts on a Wednesday, take the tablet with “Wed” next to it. Follow the direction of the arrows on the tablet map until you have taken all 21 tablets.

Then take a tablet break for 7 days. During these 7 tablet-free days (also known as the rest week), the bleeding should begin. This so-called dropout bleeding normally begins on the 2nd or 3rd day of the week of stay.

On the 8th day after the last tablet of Midiana (ie after a break of 7 days), you should start with the next tablet chart, even if the bleeding has not stopped. This means that you should start all tablet charts on the same day of the week and that the dropout bleeding should occur on the same day of each month.

If you use Midiana in this way, you will also be protected against pregnancy for the 7 days you do not take a tablet.

When can you start with the first tablet map?

If you have not used a contraceptive with hormone your previous monthStart with Midiana on the first day of the menstrual cycle (the day you get your period). If you start taking Midiana on the first day of your period, you will receive immediate protection against pregnancy. You can also start days 2–5 of the menstrual cycle, but then you must use another method of contraception (eg condoms) for the first 7 days.
Switching from a combined hormonal contraceptive (combined contraceptive pill , contraceptive ring or contraceptive patch )You should preferably start with Midiana the day after you take the last active tablet (the last tablet containing the active substances) of your previously combined oral contraceptives , but no later than the day after stopping the tablet with your previous oral contraceptives (or after the last inactive tablet of your previous birth control pills ).When changing from a contraceptive ring or a contraceptive patch , follow the advice given to you by your doctor.
Switching from a contraceptive that contains only progestogens ( mini-pills , contraceptive syringe , implants or IUDs)You can change from mini-pills at any time (from implants or IUDs on the day it was removed, from the contraceptive syringe at the time of the next injection ) but in all these cases you must use a complementary method of contraception (eg condoms) during the first 7 days you take Midiana.
After a miscarriageFollow your doctor’s instructions.
After a birthYou can start taking Midiana between 21 and 28 days after giving birth. If you start later than day 28, you must use a so-called barrier method (eg condom) for the first 7 days of taking Midiana.If you have had intercourse after giving birth before starting to take Midiana (again), you must first check that you are not pregnant or wait until the next menstrual period.
If you are breast-feeding and want to start taking Midiana (again) after giving birthRead the section on “Breastfeeding”.

Ask your doctor what to do if you are not sure when to start.

If you take more Midiana than you should

There are no reports of adverse effects from taking too many Midiana tablets.

If you take several tablets at the same time, you may feel nauseous or vomit or bleed from the vagina.

Even girls who have not yet menstruated can have such bleeding if they have taken this medicine by mistake.

If you forget to take Midiana

If it has been less than 12 hours since you were to take a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets at the usual time.
If it has been more than 12 hours since you were taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk that you will become pregnant.

The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or end of the tablet chart. Therefore, follow the rules below (see also the diagram below):

You have forgotten more than one tablet on the tablet map

Contact a doctor.

You forgot a tablet week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue to take the tablets at the usual time and use a complementary method of contraception (eg condom) for the next 7 days. If you have had intercourse the week before you forgot the tablet, you may be pregnant. In this case, contact a doctor.

You forgot a tablet week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue to take the tablets at the usual time. The protection against pregnancy is not reduced and you do not need to use an additional method of contraception. If you forget more than one tablet, use a complementary barrier method (eg condom) for 7 days.

You forgot a tablet week 3

You can choose between two options:

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue to take the tablets at the usual time. Instead of seven tablet-free days, start with the next tablet chart as soon as you take the last tablet. You will probably have a hemorrhage at the end of the second tablet chart, but you may also experience a slight menstrual-like hemorrhage during the second tablet chart.
You can also stop with the tablet map and go directly to the tablet break (note which day you forgot the tablet) . If you want to start with a new tablet map on your fixed start day, the tablet break should be shorter than 7 days .

If you follow one of these two recommendations, you will continue to be protected against pregnancy.

If you have forgotten one of the tablets on a map and you do not experience any bleeding during the first tablet break, you may be pregnant. Contact a doctor before starting the next tablet chart.

Do this in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking a tablet or if you develop severe diarrhea, there is a risk that the active substances in the tablet have not been fully absorbed by your body. The situation is almost the same as if you forgot a tablet. After vomiting or diarrhea, you must take a tablet from a spare card as soon as possible. If possible, the tablet should be taken within 12 hours after you would normally take the tablet. If this is not possible or if more than 12 hours have passed, follow the advice in “If you forget to take Midiana”.

If you want to postpone your period: you need to know this:

Even if it is not recommended, you can postpone your period by skipping the 7 tablet-free days and immediately continue with a new tablet map Midiana and end it. You may experience slight or menstrual-like bleeding when using the other tablet map. After the usual 7-day tablet break, start with the next tablet chart.

You should consult a doctor and ask for advice before you decide to postpone a menstrual period.

Changing the first day of menstruation: this is what you need to know

If you take the tablets according to the instructions, your menstruation will begin during the 7 tablet-free days. If you have to change the day, make the tablet break shorter (but you must never extend it – 7 days is the maximum!). Example: If you start the 7-day tablet break on a Friday, and you want to change it to a Tuesday (3 days earlier), start with a new tablet chart 3 days earlier than usual. If you make the tablet break very short (eg 3 days or less) you may not experience any bleeding during this time. You can then have a light or menstrual-like bleeding later.

If you are not sure what to do, talk to your doctor.

If you stop taking Midiana

You can stop taking Midiana whenever you want. If you do not want to get pregnant, you can ask your doctor for advice on other reliable contraceptive methods.

If you want to get pregnant, stop taking Midiana and wait for your regular period before trying to conceive. This will make it easier to calculate the expected date of birth.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, especially if they are severe or persistent, or if your health changes and you think it may be due to Midiana, talk to your doctor.

An increased risk of blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries ( arterial thrombosis, ATE) is present for all women taking hormonal combined contraceptives. For more information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before using Midiana”.

Below is a list of side effects that have been associated with the use of Midiana.

Common side effects ( may affect up to 1 in 10 people)

menstrual disorders, menstrual bleeding, chest pain, sore breasts
headache, depressed state
migraine
nausea
thick, whitish discharge from the vagina, yeast infection in the vagina

Uncommon side effects ( may affect up to 1 in 100 people)

breast augmentation, altered sex drive
high blood pressure , low blood pressure
vomiting, diarrhea
acne , rash, severe itching , hair loss ( alopecia )
vaginal infection
fluid accumulation in the body
altered body weight

Rare side effects ( may affect up to 1 in 1,000 people)

allergic reactions (hypersensitivity), asthma
excretion from the breasts
impaired hearing
the skin diseases erythema nodosum (characterized by painful reddish lumps of skin) or erythema multiforme (rash with annular redness or sores)
dangerous blood clots in a vein or artery , e.g.
- in one leg or foot (ie DVT)
- in the lungs
- myocardial infarction
- stroke
- ministroke or transient stroke-like symptoms, called transient ischemic attack ( TIA )
- blood clots in the liver, stomach / intestines, kidneys or eyes.
  The risk of developing a blood clot may be higher if you have other conditions that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and the symptoms of a blood clot).

How to store Midiana

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in the original package. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the package and other information

Content declaration

The active substances are 0.03 mg ethinyl estradiol and 3 mg drospirenone in each tablet.
Other ingredients are:

Tablet core: lactose monohydrate, pregelatinized maize starch, maize starch, povidone K-25, magnesium stearate

Coating: polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, lecithin (soy)

What the medicine looks like and contents of the pack

White or off-white, round, biconvex film-coated tablet. Embossing on one side: “G63”, no embossing on the other side.

Midiana 0.03 mg / 3 mg film-coated tablets are packaged in PVC / PVDC / Al calendar blister packs.

The blister packs are packed in a folding box with a package leaflet. A storage case is included in each box.

Pack sizes:

1 × 21 film-coated tablets

3 × 21 film-coated tablets

6 × 21 film-coated tablets

13 × 21 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömrői out 19-21.

1103 Budapest,

Hungary

This medicinal product is authorized under the European Economic Area under the names:

Belgium: Drosana 30

Hungary: Katul

Luxembourg: Drosana 30

The Netherlands: Colina

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Midiana – Ethinyl estradiol / Drospirenone uses, dose and side effects

What Midiana is and what it is used for